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Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00097071
First received: November 17, 2004
Last updated: December 21, 2016
Last verified: December 2016
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Purpose
This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Diabetes Mellitus, Type 1 | Drug: insulin lispro Drug: insulin aspart | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps in Children and Adolescents With Type 1 Diabetes |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
U.S. FDA Resources
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- HbA1c [ Time Frame: After 16 weeks treatment ]
Secondary Outcome Measures:
- Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events
| Enrollment: | 299 |
| Study Start Date: | October 2004 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 1 Diabetes
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097071
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00097071
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Locations
| United States, Alabama | |
| Novo Nordisk Investigational Site | |
| Mobile, Alabama, United States, 36617 | |
| Novo Nordisk Investigational Site | |
| Montgomery, Alabama, United States, 36106 | |
| United States, Arizona | |
| Novo Nordisk Investigational Site | |
| Phoenix, Arizona, United States, 85016 | |
| United States, Arkansas | |
| Novo Nordisk Investigational Site | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| Novo Nordisk Investigational Site | |
| Loma Linda, California, United States, 92354 | |
| Novo Nordisk Investigational Site | |
| Sacramento, California, United States, 95816 | |
| Novo Nordisk Investigational Site | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Novo Nordisk Investigational Site | |
| Denver, Colorado, United States, 80262 | |
| Novo Nordisk Investigational Site | |
| Englewood, Colorado, United States, 80110 | |
| United States, Connecticut | |
| Novo Nordisk Investigational Site | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| Novo Nordisk Investigational Site | |
| Orlando, Florida, United States, 32806-1101 | |
| Novo Nordisk Investigational Site | |
| St. Petersburg, Florida, United States, 33701 | |
| Novo Nordisk Investigational Site | |
| Tallahassee, Florida, United States, 32308 | |
| United States, Georgia | |
| Novo Nordisk Investigational Site | |
| Atlanta, Georgia, United States, 30318 | |
| United States, Idaho | |
| Novo Nordisk Investigational Site | |
| Idaho Falls, Idaho, United States, 83404-7596 | |
| United States, Indiana | |
| Novo Nordisk Investigational Site | |
| Indianapolis, Indiana, United States, 46202-2879 | |
| United States, Iowa | |
| Novo Nordisk Investigational Site | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Novo Nordisk Investigational Site | |
| Topeka, Kansas, United States, 66606 | |
| Novo Nordisk Investigational Site | |
| Wichita, Kansas, United States, 67226 | |
| United States, Louisiana | |
| Novo Nordisk Investigational Site | |
| Baton Rouge, Louisiana, United States, 70808 | |
| United States, Maryland | |
| Novo Nordisk Investigational Site | |
| Baltimore, Maryland, United States, 21229 | |
| Novo Nordisk Investigational Site | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Novo Nordisk Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| Novo Nordisk Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| Novo Nordisk Investigational Site | |
| Springfield, Massachusetts, United States, 01107 | |
| Novo Nordisk Investigational Site | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Novo Nordisk Investigational Site | |
| Detroit, Michigan, United States, 48202-2689 | |
| United States, Minnesota | |
| Novo Nordisk Investigational Site | |
| Minneapolis, Minnesota, United States, 55416 | |
| Novo Nordisk Investigational Site | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Novo Nordisk Investigational Site | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Nebraska | |
| Novo Nordisk Investigational Site | |
| Omaha, Nebraska, United States, 68114 | |
| Novo Nordisk Investigational Site | |
| Omaha, Nebraska, United States, 68198-3020 | |
| United States, New Jersey | |
| Novo Nordisk Investigational Site | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Novo Nordisk Investigational Site | |
| Bronx, New York, United States, 10467 | |
| Novo Nordisk Investigational Site | |
| Brooklyn, New York, United States, 11219 | |
| Novo Nordisk Investigational Site | |
| Buffalo, New York, United States, 14222 | |
| Novo Nordisk Investigational Site | |
| Manhasset, New York, United States, 11030 | |
| United States, North Carolina | |
| Novo Nordisk Investigational Site | |
| Asheville, North Carolina, United States, 28803 | |
| Novo Nordisk Investigational Site | |
| Chapel Hill, North Carolina, United States, 27599-7220 | |
| United States, Ohio | |
| Novo Nordisk Investigational Site | |
| Columbus, Ohio, United States, 43203 | |
| United States, Oklahoma | |
| Novo Nordisk Investigational Site | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Novo Nordisk Investigational Site | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Novo Nordisk Investigational Site | |
| Hershey, Pennsylvania, United States, 17033 | |
| Novo Nordisk Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Novo Nordisk Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, South Carolina | |
| Novo Nordisk Investigational Site | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Novo Nordisk Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| Novo Nordisk Investigational Site | |
| San Antonio, Texas, United States, 78284 | |
| United States, Virginia | |
| Novo Nordisk Investigational Site | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Novo Nordisk Investigational Site | |
| Seattle, Washington, United States, 98105 | |
| United States, West Virginia | |
| Novo Nordisk Investigational Site | |
| Charleston, West Virginia, United States, 25302 | |
| United States, Wisconsin | |
| Novo Nordisk Investigational Site | |
| Milwaukee, Wisconsin, United States, 53226-0509 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
Additional Information:
Publications:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00097071 History of Changes |
| Other Study ID Numbers: |
ANA-2181 |
| Study First Received: | November 17, 2004 |
| Last Updated: | December 21, 2016 |
Keywords provided by Novo Nordisk A/S:
|
Diabetes, Type 1 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin, Globin Zinc Insulin Insulin Aspart Insulin Lispro Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 21, 2017